Laser Vaginal Treatment for GSM

Sunnybrook Health Sciences Centre60 enrolled

Overview

Genitourinary Syndrome of Menopause (GSM) due to low estrogen levels affects about half of post-menopausal women and may have a dramatic impact on women's quality of life. Women complain of vaginal dryness, itching, discomfort, malodour, painful intercourse and may have urinary urgency, irritation, bladder/urethral pain and recurring bladder infections. First-line therapies include vaginal moisturizers, lubricants and estrogen (either oral or with vaginal cream/tablets). While these therapies are effective, the ongoing costs and the resistance to the indefinite use of vaginal creams/inserts is a challenge to the continued use of these therapies. Recently, an innovative laser therapy has been used to treat women with GSM. A randomized controlled trial (RCT) to study how effective the laser is to treat women with GSM is planned.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Menopausal Urethral Atrophy Vulvar Atrophy

Interventions

Eligibility

Sex: FEMALEMin age: 45 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Females aged 45-70 years; 2. 2 or more years since last natural menstrual period, or surgical menopause (bilateral oophorectomy); 3. at least 1 vaginal symptom reported from the following list, experienced for the past 30 days which is moderate or severe at least once a week: dryness \| itching \| irritation \| soreness/pain \| dyspareunia; 4. no concurrent or new planned treatment for GSM during the treatment period and the 3 months following it; 5. vaginal anatomy allows for laser therapy; 6) willing and able to comply with the study protocol. Exclusion Criteria: 1. Patient is pregnant/lactating 2. unexplained abnormal genital bleeding 3. current acute vaginal/ bladder infection 4. antibiotic use the past 30 days; 5. women under age 55 with endometrial ablation/ hysterectomy/ at least one ovary; 6. concurrent use of any other new GSM treatment 7. pelvic surgery \<3 months 8. current treatment for chronic pelvic pain

Outcomes

Primary Outcomes

subjective measure of change in: the patient's most bothersome symptom

The most bothersome symptom of GSM (vaginal dryness, discomfort, itching, dyspareunia, urinary urgency, dysuria) will be identified and its severity rated on a standardized 4-point scale: 0=none, 1=mild, 2=moderate, 3=severe

Time frame: Baseline and 3 months after treatment start